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News

FDA panel's recommendation that liposome inhalation suspension be labeled only for refractory nontuberculous mycobacterial lung disease and not first-line use aligns with analyst expectations; panel cites lack of clinical studies in treatment-naive patients and adverse event profile as reasons for limiting drug to patients with limited or no treatment options.

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Opinion

Pharma companies have responded to mounting political pressure to lower drug prices by pledging to limit increases and even roll back the costs of certain drugs, but it's hard to keep track of who has promised what exactly. Here, Scrip provides a listing of pharma pricing pledges.

Analysis

A 60% price reduction on hepatitis C drug Zepatier sounds impressive, but the drug has been declining and the HCV space overall is shrinking. Another set of 10% reductions come on small-sellers that are now generic.

Analysis

Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.

News

After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.

Analysis

India's cut-price generic drugs scheme appears to have gathered some pace, covering over 700 medicines, offering sharp price differentials over brand name therapies and also garnering some private sector interest. But its on-ground impact in improving affordable access to medicines is still limited, some experts claim.

Analysis

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing.

News

In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake.

News

Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.

Opinion

President Trump called out Pfizer’s recent price increases on Twitter July 9. Pfizer was one of only four companies that took a second round of price increases in 2018, according to analysts at Morgan Stanley. CEO Read has long defended the industry's pricing practices, even as public criticism of the high drug prices has grown.